Description
Packing
28 pcs.
Pharmacological action
Omeprazole – proton-inhibiting proton pump, antiulcer.
Pharmacodynamics
Omeprazole inhibits the enzyme H + – K + -ATPase (“proton pump”) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral administration, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. In patients with peptic ulcer of the duodenum, taking 20 mg of omeprazole maintains an intragastric pH = 3 for 17 hours. After discontinuation of the drug, secretory activity is fully restored after 3-5 days.
Pharmacokinetics
Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5 1 hours. Bioavailability is 30 40%. Plasma protein binding is about 90%. Omeprazole is almost completely metabolized in the liver. T1 / 2 – 0.5 1 hours. It is excreted mainly by the kidneys in the form of metabolites. In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients, excretion decreases, bioavailability increases. With liver failure, bioavailability is 100%, T1 / 2 – 3 hours.
Indications
peptic ulcer of the stomach and duodenum
reflux esophagitis
erosive-ulcerative lesions of the stomach and duodenal ulcer associated with the administration of NSAIDs
stress ulcers of the gastric ulcer
Zollinger-Ellison syndrome.
Contraindications
hypersensitivity to the drug
children
pregnancy
lactation.
Use during pregnancy and lactation
Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.
Composition
1 capsule contains:
Active ingredient: omeprazole 40 mg
Excipients: gelatin glycerin nipagin nipazole sodium lauryl sulfate titanium dioxide water purified colorant E 129.
Dosage and administration
Inside, with a little water (do not chew the contents of the capsule).
Peptic ulcer of the duodenum in the exacerbation phase – 1 capsule (40 mg) per day for 2-4 weeks (in resistant cases – up to 2 capsules per day).
Peptic ulcer in the exacerbation phase and erosive-ulcerative esophagitis – 1-2 capsules per day for 4-8 weeks.
Erosive and ulcerative lesions of the gastrointestinal tract caused by NSAIDs – 1 capsule per day for 4-8 weeks.
Eradication of Helicobacter pylori – 1 capsule 2 times a day for 7 days in combination with antibacterial agents.
Anti-relapse treatment of peptic ulcer of the stomach and duodenum – 1 capsule per day.
Anti-relapse treatment of reflux esophagitis – 1 capsule per day for a long time (up to 6 months).
Zollinger-Ellison syndrome – the dose is selected individually depending on the initial level of gastric secretion, usually starting at 60 mg / day. If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2 doses.
Side effects of
From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in plasma liver enzymes in patients with previous severe liver disease – hepatitis ( including with jaundice), impaired liver function.
From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations in patients with severe concomitant somatic diseases, in patients with previous severe liver disease – encephalopathy.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
From the hemopoietic system: leukopenia, thrombocytopenia in some cases – agranulocytosis, pancytopenia.
From the skin: itching rarely (in some cases) – photosensitivity, erythema multiforme, alopecia.
Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock.
Other: visual impairment, peripheral edema, increased sweating, fever, gynecomastia rarely – the formation of gastric glandular cysts during prolonged treatment (due to inhibition of hydrochloric acid secretion, is benign reversible).
Drug Interaction
Long-term administration of omeprazole at a dose of 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporin concentrate .
No interaction with concurrent antacids was noted.
Changes the bioavailability of any drug, the absorption of which depends on the pH value (eg iron salts).
Overdose
Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: symptomatic. There is no specific antidote. Hemodialysis is not effective enough.
Storage conditions
In a dry, dark place at temperatures below 25 ° C.
Expiration
2 Year
Pharmacy Terms
pharmacies Prescription
dosage form
dosage form
capsules
Teva Pharmaceutical Enterprise Co., Ltd., Israel
